Implant containing rods

ABSTRACT

An implant that has a tubular interior section for implantation into a patient, an exterior section connected to the interior section and an ingrowth member that includes a three-dimensional porous structure. The three-dimensional porous structure is typically located at the inner circumference of the interior section and has desirable properties to facilitate ingrowth of tissue.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/774,505 filed Sep. 10, 2015, which is a 371 filing of Internationalpatent application no. PCT/EP2014/055207 filed Mar. 14, 2014, whichclaims the benefit of British application no. 1304649.5 filed Mar. 14,2013.

BACKGROUND

The present invention relates to an implant, particularly a percutaneousostomy implant, and a surgical method, which may use that implant,preferably for creating a continent reservoir in communication with apercutaneous port.

Ileostomy and colostomy are common operations which may be necessitated,for example, by malignancy or chronic bowel inflammation. The surgery iscalled an ileostomy if the colon and rectum are removed and a colostomyif the rectum alone is removed. Similarly an abdominal urostomy iscreated when the urinary bladder has to be removed due to, for example,bladder cancer. In these operations, a stoma is formed in the abdominalwall to which a bowel segment is connected.

Ostomy is a generic term for any such procedure where a stoma iscreated.

The stoma, in most cases, has to be connected to a bag for thecollection of bodily waste. However, instead of a conventionalileostomy, it is possible to make a reservoir known as a “Kock pouch”from the distal part of the ileum. The pouch is formed in such a waythat a nipple valve is created which serves to close the reservoir,whilst allowing it to be drained intermittently by means of a catheter.This is an example of a so-called continent ileostomy (CI) and it wasformerly an attractive alternative to conventional ileostomy but is nowrarely used. The complexity of the procedure and the high potential forcomplications—most of them related to dysfunction of the continencenipple valve—has deterred many surgeons from adopting the operationtoday.

The ileopouch anal anastomosis (IPAA) is today the gold standardworldwide for these patients but, as with a CI, this operation is alsorisky and failures are common, mostly leading to pouch excision withloss of bowel. Conversion of a failed IPAA to a CI would be a preferableoption but, again, surgeons are reluctant to perform this complex andunreliable technique. Likewise, conversion of a malfunctional orthotopicneobladder or Bricker urostomy would be desirable.

In its earlier patent application EP 1632201 A1, the present applicantdisclosed a percutaneous ostomy implant comprising a solid-walledcylindrical body and an anchoring section in the form of a circularflange. The device was designed to be implanted through the abdominalwall and secured by an anchoring section located below the fascia, abovethe muscle layer. This section comprised inner and outer concentricrings interconnected by S-shaped members in order to provide an axiallyresilient structure which could absorb shear stresses and consequentlyreduce the risk of tissue damage. Spaces around the S-shaped members andthe provision of numerous apertures in the rings allowed for tissueingrowth and vascularisation. It was proposed to connect the device tothe side of the bowel wall and by providing a removable lid on thecylindrical body a continent ostomy could be provided.

U.S. Pat. No. 6,017,355 discloses another solid-walled implant. This wasprovided with a fabric coating comprising Dacron velour which wasintended to encourage tissue ingrowth.

A development of this implant was disclosed in WO 2007/099500 in whichthe solid-walled cylindrical body was replaced by an axially outertubular part spaced from the anchoring section bycircumferentially-spaced legs. The tubular part penetrated the skin andformed a ring for connection to a bag or lid. This implant was designedto receive a bowel section drawn up through it; the spaces between thelegs allowed the generation of a tissue bond between the inner part ofthe abdominal wall and the serosal tissue of the bowel in order toprovide a more secure, stable, leak-proof and well-vascularisedtissue-implant junction. In some embodiments, a circumferential ingrowthmesh was additionally provided. This extended along most of the lengthof the tubular part with an annular gap being provided between it andthe tubular part to facilitate growth of serosal tissue through themesh.

In a further development, disclosed in WO 2009/024568, the presentapplicant proposed a cylindrical body formed of two axially-spacedtubular parts. The outer tubular part penetrated the skin and provided aconnecting ring. The inner tubular part was attached to an anchoringflange of the type previously described. The two parts were connectedtogether by a “distance means” comprising either radially-spaced legs ora rigid cylindrical ingrowth mesh which allowed for the generation of atissue bond between the abdominal wall and the bowel. By means of thisarrangement, a break was provided in the possible infection path alongthe implant from the skin.

In a still further development, the applicant disclosed in WO2010/125346 a percutaneous ostomy implant comprising a cylindrical partfor mounting an external detachable device, a cylindrical ingrowth meshand a circular flange for anchoring the implant. The cylindrical partand circular flange were attached to opposite ends of the ingrowth mesh,with the mesh extending inside the cylindrical part. The implant wasconfigured such that when it is implanted in the abdominal wall of apatient, abdominal tissue including the epidermis meets the ingrowthmesh and is able to attach therethrough directly to serosal tissue of abowel segment inside the implant. Thus, it was based on the hypothesisthat by allowing the epidermis to attach directly to the serosal tissue,bacterial infection (i.e. bacterial attachment to implant surface andsubsequent migration) can be prevented.

However, whilst this implant was found to be effective in ensuring soundattachment of the serosal tissue to the abdominal tissue, it had adrawback in that it became more difficult to ensure a fluid-tight sealbetween the exterior parts of the implant and the bowel segment. Thiswas because the implant relied upon the bowel segment extending withinthe cylindrical part and maintaining secure infiltration of serosaltissue through the mesh inside that part to form a good seal to theimplant. If the bowel receded below the cylindrical part, a leakage pathcould be formed through the mesh, even if the bowel segment andabdominal wall remained integrated and the implant remained secure andfree of infection.

WO 2011/126724 discloses a stoma stabilising device intended to preventstomas from constricting over time and hence requiring surgicalre-opening. The preferred embodiments comprise a flexible mesh tube witha radially extending mesh anchoring flange. In some variants, multiplelayers of mesh may be employed.

In WO 2012/131351, the applicant presented further developments relatingto percutaneous ostomy implants comprising a connecting member, a firsttubular ingrowth member and a second tubular ingrowth member radiallyoutwardly spaced from the first tubular ingrowth member, aradially-extending dermal anchor to engage the abdominal wall beneaththe dermis, and/or a tubular ingrowth member arranged around theconnecting member. This implant was formed by a laser cutting process.

However, in trials, this implant was still found to have problems. Forexample, this implant was fixed to the muscle sheath with an anchorprovided at the bottom. This was not ideal with patients adding orlosing weight since the implant height was fixed and the thickness of apatient's abdomen could vary over time. There was also insufficientingrowth at the top of the implant. These factors could lead to skinproblems, implant overgrowth, excessive implant protrusion and leakagefrom the system.

SUMMARY OF THE INVENTION

According to one aspect of the invention, there is provided an implantcomprising a tubular interior section for implantation into a patientand an exterior section connected to the interior section, a surface ofthe exterior section comprising a three-dimensional porous structure atan inner circumference thereof. By providing a three-dimensional porousstructure at an inner surface of the exterior section, this provides aingrowth means into which tissue can grow. By providing athree-dimensional structure, this can provide better and more secureingrowth than previously used two-dimensional ingrowth means. Athree-dimensional ingrowth porous structure can provide a “skeleton”structure for tissue ingrowth and creates a physiological need thatpromotes cellular ingrowth into the structure. Accordingly, in oneclaimed aspect of the invention, the porous structure is rigid.Furthermore, by providing the three-dimensional porous structure at theexterior section, this can lead to more ingrowth at the outer end of theimplant, making it more secure at the exterior end and reducing thepossibility of leakage from the system.

Preferably, there is no gap between the three-dimensional porousstructure and the rest of the exterior section.

The porous structure is preferably connected to the rest of the exteriorsection at least at first and second end regions thereof, and/orpreferably at a number of points over the height of the porousstructure.

Preferably, the porous structure extends to an exterior end (top) of theexterior section. In this way, a bowel segment, for example, may besecured by ingrowth right up to the top end of the implant, therebyproviding a more secure implantation of the implant and also reducingthe likelihood of leakage. Alternatively, the porous structure mayextend to within 1 mm, 2 mm or 3 mm of the exterior end (top) of theexterior section.

The implant may be, for example, an ostomy implant, such as apercutaneous ostomy implant, which is suitable for implantation into theabdominal wall of a patient.

The tubular interior section may be substantially cylindrical but may beof generally any form with an opening along a longitudinal axis thereof.The opening should ideally be large enough for a bowel segment to passtherethrough.

The shape and/or size (e.g. the internal and/or external diameter) ofthe cross-section of the interior section may vary along its length.

The exterior section may be generally ring-shaped, tubular orcylindrical, for example.

The exterior and/or interior sections may have a substantially circularcross-section.

The exterior section is ideally coaxial with the interior section.

The exterior section may have an outer diameter (measured from its outeredges) of 10-60 mm, more preferably 25-35 mm or 25-30 mm.

The exterior section may have an inner diameter (measured from its inneredges) of 5-55 mm, more preferably 15-30 mm or 20-25 mm.

The interior section may have an inner diameter (measured from its inneredges) at its narrowest point of 5-55 mm, more preferably 15-30 mm or20-25 mm.

Implants whose exterior and interior sections have a smaller innerdiameter (i.e. towards the lower ends of the scales mentioned above) maybe particularly useful for urostomies. Implants whose exterior andinterior sections have a larger inner diameter (i.e. towards the upperends of the scales mentioned above) may be particularly useful forcolostomies.

The interior and exterior sections may have circular cross-sections orany other shape. Thus, since the cross-sections of these sections neednot necessarily be circular, references to “diameter” above refer to themaximum distance measured perpendicularly across the sections.

Preferably, the interior and exterior sections have the samecross-section (e.g. in size and/or shape), at least at the point wherethe sections meet.

The porous structure is preferably arranged around the entire innercircumference of the exterior section. Alternatively, the porousstructure may be provided around at least 70%, at least 75%, at least80%, at least 85%, at least 90%, at least 95%, at least 97%, at least98% or at least 99% of the inner circumference of the exterior section.By providing all, or at least a significant part of the innercircumference of the exterior section with a porous structure, thisensures that ingrowth means is provided around all, or at least asignificant part, of the inner circumference of the exterior section sosecure and sufficient ingrowth may be obtained.

The porous structure preferably has a thickness (or a minimum thickness)of at least 0.5 mm, at least 0.6 mm, at least 0.7 mm, at least 0.8 mm,at least 0.9 mm, at least 1.0 mm, at least 1.1 mm, at least 1.2 mm, orat least 1.25 mm. In preferred embodiments, the porous structure has athickness of around 1.25 mm or 1.75 mm. By providing a porous structureof at least 0.5 mm (or greater) thick, this means that the porousstructure may be formed of a number of layers (e.g. two or three layers)and helps to ensure secure ingrowth into the porous structure. Thethickness of the porous structure may be measured in a radial directionwith respect to the longitudinal axis of the implant.

The porous structure should ideally also be thin enough that there isenough space inside the exterior section for a bowel segment to passthrough it. Thus, preferably the porous structure has a thickness of 3.0mm or less, 2.5 mm or less, or 2.0 mm or less. The thickness of theporous structure may be in a range of 0.5 to 2.0 mm, 2.5 mm, or 3.0 mm,for example.

Preferably, the porous structure is completely permeable and has no deadends. For example, each passage entering the porous structure ideallyalso has an exit. Alternatively, at least 80%, at least 85%, at least90%, at least 95%, or at least 97% of the openings into the porousstructure have a corresponding exit. This can provide the most secureingrowth into the ingrowth means.

The thickness of any member forming the porous structure is preferablyless than or equal to 500 μm, less than or equal to 450 μm, less than orequal to 400 μm, less than or equal to 350 μm, or less than or equal to300 μm. The thickness of any member forming the porous structure ispreferably greater than or equal to 100 μm, greater than or equal to 125μm, greater than or equal to 150 μm, or greater than or equal to 200 μm.By providing a porous structure formed of members with such dimensions,this means that the porous structure has dimensions which arebiologically comfortable (mimicking coral, for example), therebycreating a physiological need which promotes secure ingrowth of tissueinto the porous structure.

For similar reasons, preferably, the maximum diameter of any opening inthe porous structure is 500 μm, 450 μm, 400 μm, 350 μm, 300 μm, 250 μm,200 μm or 150 μm. The minimum diameter of any opening in the porousstructure may be 50 μm, 75 μm, 100 μm or 125 μm, for example. Thediameters of any openings (or of at least 70%, 75%, 80%, 85%, 90% or 95%of the openings) in the porous structure are preferably in a range of100 to 400 μm, more preferably, 150 to 350 μm, more preferably 250 to350 μm, more preferably 275 to 325 μm.

The cross-sections of any members and/or openings in the porousstructure may be circular or any other regular or irregular shape suchas elliptical, super-elliptical, quadratic with rounded corners,hexagonal, octagonal, polygonal, polygonal with rounded corners, orrectangular with rounded corners, for example. Thus, since thecross-sections of the members and/or openings forming the porousstructure need not necessarily be circular, references to “diameter”above refer to the maximum distance measured perpendicularly across amember and/or an opening in the porous structure.

In further optimised embodiments, both the members forming the porousstructure and the openings of the porous structure may varyindependently in size and/or shape within one porous structure, in arandom or structured (regular) pattern.

The porous structure preferably has a height of at least 3 mm, at least4 mm, at least 5 mm, or at least 6 mm, where the height is the length ofthe porous structure measured in a direction parallel to thelongitudinal axis of the implant.

The porous structure preferably has a height of less than 10 mm, lessthan 8 mm, less than 8 mm or less than 7 mm.

Preferably, the height of the porous structure is in a range from 3 to 9mm, more preferably from 4 to 8 mm, more preferably from 5 to 7 mm, morepreferably from 6 to 7 mm.

In a preferred embodiment, the height of the porous structure is 6.35mm.

The porous structure has a height that is ideally great enough toprovide a sufficiently large ingrowth zone, but also small enough thatthere is limited implant protrusion above skin level (the porousstructure being ideally located within the exterior section).

However, in some embodiments the porous structure may extend into theinterior section and/or a further porous structure (for example with anyof the features discussed in relation to the first porous structure) maybe provided in the interior section. Thus, a porous structure with aheight of up to around 40 mm may be provided. Such a porous structurecould extend from the exterior section into the interior section.

The porous structure may be flexible, semi-flexible or rigid.

The porous structure is preferably integral with the rest of theexterior section. This means that the exterior section, at least, can beformed as a single element (for example with the rest of the implant aswell) and there is no need to attach a porous structure inside theexterior section.

The porous structure is preferably made from a biologically acceptablematerial such as titanium. This helps to prevent patients reactingadversely to the implant. Preferably, a commercially pure titanium isused such as medical grade 2 titanium. Examples of other materials thatcould be used include titanium grades according to ASTM F67 (ISO 5832)medical grade 1, 2, 3, 4 or 5, specifically grade 5 Ti64ELI, otherbiocompatible metals and alloys such as Elgiloy, or achrome-cobalt-molybdene alloy, biocompatible ceramics and biocompatiblepolymers.

The porous structure may be formed from interconnecting members. Themembers may be arranged in layers (e.g. concentric layers), for example.The layers could be connected by connecting members. Accordingly, theconnecting members will typically have a radial extent. These arepreferably two to four layers, but more preferably three.

The members may form a regular, repeating pattern throughout the porousstructure. For example, the porous structure could be formed from aplurality of repeating units.

Alternatively, the porous structure may have an irregular or partlyirregular structure.

In either case it will be appreciated that the porous structure istypically porous in multiple directions (i.e. passages through thestructure extend in multiple directions) so that a coral-like structureis provided. This is in contra-distinction from conventional mesh whichis essentially two-dimensional, with porosity (and passageways)extending in only one direction, relative to the surface of the mesh.

Preferably, the exterior section comprises engagement means (e.g. aengagement mechanism) for engaging with a device. For example, theexterior section may comprise one or more grooves, recesses orindentations into which corresponding attachment means provided on a lidor other device may be attached. Preferably, the engagement means arelocated on an exterior surface of the implant, or at the very top of theinner surface of the implant, so that tissue inside the implant is notaffected when a device is attached to the implant.

Alternative engagement means include: a threaded interface for screwinga device onto the implant, a bayonet attachment, a magnetic interface(i.e. one or more magnets arranged on the implant), a rubber orrubber-like material encompassing the outer perimeter, or like a cork inthe inner diameter, for example, of the implant.

In some embodiments, at an inner end, the interior section may comprisea radially extending part, for example in a cone or trumpet-like shape.This can help to secure the implant in a patient's body as it can resistforces acting on the implant in more directions.

Alternatively or additionally, the implant may comprise an anchoringflange extending radially outwardly from the interior section. This canalso help to secure the implant in a patient's body.

The anchoring flange may extend to a greater radius than the radiallyextending part (if both such components are provided).

The anchoring flange may extend perpendicularly from the implant.However, it is preferred that it extends at an angle of less than 90°such that it is sloping towards the interior end of the implant. Theanchoring flange may be curved. These features can allow the anchoringflange to follow the general curvature of a patient's body, reducing thelikelihood of damage or problems caused by its implantation.

The anchoring flange may be formed of or comprise an ingrowth means(e.g. an ingrowth part) such as a mesh, e.g. a hexagonal mesh. Such aningrowth means can allow body tissue to grow into the flange and securethe implant in the body.

The interior section preferably extends longitudinally inwardly (i.e.downwardly as shown in the figures) from a point at which the anchoringflange is connected to it. The interior section may additionally oralternatively extend longitudinally outwardly (i.e. upwardly as shown inthe figures) from a point at which the anchoring flange is connected toit.

The implant may be flexible, semi-flexible or rigid. In some embodimentsthe flexibility/rigidity of the implant may vary over its structure. Forexample, the interior section may be more flexible than the exteriorsection so that, for example, the interior section is more adapted tothe surrounding tissue, but the exterior section is still sufficientlyrigid that a lid may be attached to it. This may be achieved by usingdifferent materials in different sections of the implant, for example.Such different materials could be joined with welds, glue, friction,threads, or other techniques.

The interior section may be formed of or comprise an ingrowth means(e.g. an ingrowth part) such as a mesh, e.g. a hexagonal mesh. Such aningrowth means can allow body tissue to grow into the interior sectionand secure the implant in the body.

The interior section may comprise a plurality of rods, the rods having adiameter of less than or equal to a biologically comfortable length suchas 500 μm, 450 μm, 400 μm, 350 μm, 300 μm, 250 μm or 200 μm. Thediameter of the rods is preferably similar to the average diameter ofhuman skin hairs, e.g. 20 to 200 μm. By forming the interior section, orpart of the interior section, from such thin components, the amount ofmaterial used to form the implant can be minimised, thereby reducing thelikelihood of a patient reacting adversely to the implant. Furthermore,since the rods have a diameter of less than or equal to a biologicallycomfortable length, this reduces the possibility of the patient's bodyrejecting or reacting adversely to the implant.

This concept is considered to be inventive in its own right, thus,according to a second aspect of the invention, there is provided animplant comprising a tubular interior section for implantation into apatient and an exterior section connected to the interior section,wherein the interior section comprises a plurality of rods and the rodshave diameters of less than or equal to 500 μm, less than or equal to450 μm, less than or equal to 400 μm, less than or equal to 350 μm, lessthan or equal to 300 μm, less than or equal to 250 μm or less than orequal to 200 μm. The diameters of the rods may be in a range of 100 to400 μm, 100 to 300 μm, 150 to 250 μm, 100 to 200 μm, 200 to 300 μm, or250 to 300 μm, for example.

Preferably, the rods have a diameter of greater than or equal to 20 μm,greater than or equal to 50 μm, greater than or equal to 75 μm, orgreater than or equal to 100 μm. In a preferred embodiment, the rodshave a diameter of 275 μm.

The rods may have a circular cross-section or any other shape. Thus,since the cross-sections of the rods need not necessarily be circular,references to “diameter” above refer to the maximum distance measuredperpendicularly across a rod.

The rods are preferably arranged circumferentially around the implant.At least some of the rods may be parallel to the longitudinal axis ofthe implant, for example.

Depending on the diameter of the rods and the material from which theyare made, ideally sufficient rods should be provided to make the implantstrong enough to withstand pulling forces acting on it, with a safetymargin, for example. The stronger the material used for forming therods, the smaller the number of rods required. Ideally, the smallestnumber of rods possible are used to keep the amount of material used toa minimum.

More than 10, 20, 30, 40, 50 or 60 rods may be provided and/or fewerthan 150, 140, 130, 120, 110, 100, or 90 rods may be provided.

Preferably, 5 to 150, 20 to 130, 40 to 110, 50 to 100, or 60 to 90 rodsare provided.

One or more of the rods is preferably slanted with respect to thelongitudinal axis of the implant. This can help to improve themechanical strength of the implant since such rods can help to withstandtorque, shearing and compressing forces acting on the implant. Forexample, the one or more slanting rods may be arranged at an angle of upto 45°, up to 40°, up to 35°, up to 30°, up to 25°, up to 20°, up to 15°or up to 10° with respect to a longitudinal axis of the implant.Preferably, the one or more slanting rods may be arranged at an angle ofat least 5°. In preferred embodiments, one or more slanting rods arearranged at angles of up to 25°.

Rods may be slanted radially inwardly or outwardly from the longitudinalaxis of the implant and/or circumferentially or sideways around theimplant. The inward or outward radial slant of the rods is preferablyless than the circumferential slant. For example, rods may be slantedradially outwards or inwards by an angle of around 15° or less, and/orrods may be slanted circumferentially by an angle of around 25° or less.Rods may be slanted circumferentially in clockwise and/or anti-clockwisedirections (when view from the top or exterior end of the implant).

One or more of the rods is preferably parallel with respect to thelongitudinal axis of the implant. Such parallel rods can help towithstand axial forces acting on the implant along its longitudinalaxis, for example.

Around 30-40%, 30-50%, 40-60%, 50-70% or more of the rods may beslanting.

Around 30-40%, 30-50%, 40-60%, 50-70% or more of the rods may beparallel.

One or more rods may have at least one end located radially inwardlywith respect to the implant compared to one or more other rods. Such anarrangement can improve the mechanical strength of the implant,particularly with respect to shear forces. Shear forces may act on animplant, for example, when a patient rises from a chair and contacts atable with the implant, moves sideways and contacts a door-post, orsimilar situations.

The inner ends of the rods (i.e. the ends of the rods located furthestfrom the exterior section of the implant) are preferably all located atthe same radius of the implant.

The exterior ends of the rods (i.e. the ends of the rods located closestto the exterior section of the implant) may be located at differentradii, for example at two or three different radii. In a preferredembodiment, the exterior ends of the rods are located on three imaginaryconcentric circles. Preferably, the concentric circles are equallyspaced.

The radial distance between the radially innermost exterior ends and theradially outermost exterior ends may correspond to the thickness of theporous structure. For example, the radial distance between the radiallyinnermost exterior ends and the radially outermost exterior ends may bearound 1.0 to 2.0 mm or 2.5 mm.

Such arrangements of the rods can result in a very rigid, box-likeoverall structure, which can help to increase the mechanical strength ofthe implant and distribute the forces acting on the exterior section ofthe implant more uniformly into the porous structure.

The rods are ideally long enough that, in use, they can extend throughthe skin (i.e. the epidermis and the dermis) and also ideally extendpartially into the hypodermis. For example, the rods may be at least 1.5mm, at least 2 mm, at least 2.5 mm, at least 3.0 mm, at least 3.5 mm, atleast 4.5 mm or at least 5.0 mm long. The rods may have a maximum lengthof 8.0 mm, 7.5 mm, 7.0 mm, 6.5 mm, 6.0 mm, 5.5 mm or 5.0 mm. In apreferred embodiment, the rods are around 4.8 mm long. Of course, theslanting rods may be slightly longer than the parallel rods. The lengthsreferred to in this paragraph may refer to the slanting or the parallelrods.

The interior section may comprise an inner interior section part and anouter interior section part.

The outer interior section part preferably comprises the plurality ofrods.

The plurality of rods may connect the inner interior section part to theexterior section.

Preferably, the inner interior section part is connected to the exteriorsection solely by the plurality of rods. This helps to minimise theamount of material used in the implant.

For similar reasons, the outer interior section part is preferablyformed solely from the plurality of rods.

The inner interior section part preferably comprises or is formed of aningrowth means (e.g. an ingrowth part), preferably in the form of a meshsuch as a hexagonal mesh. By providing such an inner interior sectionpart, this can help the implant to be implanted securely into apatient's body.

Various optional features of the aspects described above are consideredto be independently inventive.

Thus, according to another aspect of the invention, there is provided animplant comprising an ingrowth means in the form of a three-dimensionalporous structure, wherein the porous structure has a thickness of atleast 0.5 mm. For example, the porous structure could have a thicknessof at least 0.5 mm, at least 0.6 mm, at least 0.7 mm, at least 0.8 mm,at least 0.9 mm, at least 1.0 mm, at least 1.1 mm, at least 1.2 mm, orat least 1.25 mm. In preferred embodiments, the porous structure has athickness of around 1.25 mm or 1.75 mm. As discussed above, by providingan ingrowth means of at least 0.5 mm thick, this ensures that secureingrowth into the porous structure can be achieved.

According to another aspect of the invention, there is provided animplant comprising an ingrowth means in the form of a three-dimensionalporous structure, wherein the porous structure is completely permeableand has no dead ends.

Preferably, each passage entering the porous structure also has an exit.

According to another aspect of the invention, there is provided animplant comprising an ingrowth means in the form of a three-dimensionalporous structure, wherein at least 80%, at least 85%, at least 90%, atleast 95%, or at least 97% of the openings into the porous structurehave a corresponding exit.

According to another aspect of the invention, there is provided animplant comprising an ingrowth means in the form of a three-dimensionalporous structure, wherein the thickness of any member forming the porousstructure is less than or equal to 500 μm, less than or equal to 450 μm,less than or equal to 400 μm, less than or equal to 350 μm, or less thanor equal to 300 μm.

According to another aspect of the invention, there is provided animplant comprising an ingrowth means in the form of a three-dimensionalporous structure, wherein the maximum diameter of any opening in theporous structure is 500 μm, 450 μm, 400 μm, 350 μm, or 300 μm.

The implants of any of the above aspects may be a percutaneous ostomyimplant, for example. The implants may comprise a tubular interiorsection and/or a tubular or ring-shaped exterior section. The interiorand exterior sections are preferably co-axial. The ingrowth means may belocated in the interior and/or exterior section. Preferably, theingrowth means extends around the circumference of the interior and/orexterior section.

After an implant has been implanted into a patient, it is important thata bowel segment, for example, or other vessel passing through theimplant, is secured so that it can grow into the implant.

There are various ways in which the bowel segment, for example, may besecured or fixated. One conventional method is a surgical procedurereferred to as a “turnbull”. During this procedure, on a conventionalstoma the efferent part of the intestine is wrung inside out andattached to the skin surrounding the stoma. However, after thisprocedure, the stoma often retracts at skin level, leaving a space andresulting in leakage. Also, it is not possible to perform a conventionalturnbull with the implant of the above aspects because this wouldcompletely cover and hide the implant. It would then not be possible touse a stabiliser device (to hold the implant in position) during healingand it would also not be possible to monitor the healing and ingrowth ofthe implant. The risk of bodily waste being caught under the turnbulland around the implant would be great, potentially causing infection,and it would not be possible to clean and wash away such trapped waste.In previous processes with an ostomy implant, the intestine was simplyleft outside the implant or arranged into a “loose hanging turnbull”,not connected to anything, and not secured or fixed.

There is therefore a need for providing a way of securing the bowelsegment, for example, to provide a more stable environment for the stomato heal after an ostomy is performed on a patient.

According to a further aspect of the invention, there is provided anadaptor for securing a bowel segment outside a patient's body after anostomy has been performed, the adaptor comprising: attachment means(e.g. an implant attachment part) for attaching the adaptor to animplant; and securing means (e.g. a bowel segment securing part) towhich a bowel segment may be attached.

By providing such an adaptor, a turnbull procedure may be facilitatedand the bowel segment can be secured whilst it heals, thereby reducingthe likelihood of it retracting during this process. In addition, whenused with an implant according to one of the aspects of the inventiondescribed above, the bowel segment can be secured close to the porousingrowth structure (where this is provided in the exterior section ofthe implant), which further helps to keep the bowel segment in a fixedposition, and thereby provides an optimal peaceful healing situationfree from significant movements or mechanical stress.

The adaptor may be referred to as a turnbull adaptor.

The implant itself may also be secured with a stabiliser device to holdit in place during healing.

The adaptor should ideally be easy to attach to the implant with thecorrect alignment.

Preferably, the attachment means are arranged to prevent the adaptorfrom moving rotationally, horizontally and vertically with respect tothe implant, when the adaptor is attached to the implant. This helps toprevent rotational or other forces acting on the vessel during healing.

Preferably, the attachment means are arranged to attach to an outersurface of the implant, for example in a groove, recess or indentationon an outer surface of the implant. The attachment means may be arrangedto engage with one or more corresponding grooves, recesses orindentations on the implant.

In a preferred embodiment, the attachment means comprises one or moreresilient members. This is a simple way of allowing the adaptor to beattached to an implant. The one or more resilient members may compriseengagement means (e.g. implant engagement parts), such as protrudingparts, for engaging with the implant, for example in one or morecorresponding recesses on the implant.

Alternative attachment means could also be used. For example, longer orshorter resilient members could be used with corresponding grooves,recesses or indentations, for example, in a correspondingly lower ofhigher position on the implant. Different shaped protruding parts couldalso be used. Other alternatives include: a threaded interface forscrewing the adaptor onto the implant, a bayonet attachment, a magneticinterface (i.e. one or more corresponding pairs of magnets on theadaptor and the implant), a rubber or rubber-like material encompassingthe outer perimeter of the implant and/or an inner perimeter of theadaptor using only friction forces, a rubber or rubber-like materialwith a ring-like suction-cup on the adaptor for attaching to a polishedtop surface, for example, of the implant.

The adaptor preferably has an aperture through which the bowel segmentmay pass. For example, the adaptor may be substantially ring-shaped.Preferably the aperture has the same shape and/or diameter as the innershape and/or diameter of the corresponding implant. For example, theadaptor may be substantially ring-shaped or tubular. The aperture mayhave a diameter of 5-55 mm, more preferably 15-30 mm or 20-25 mm.

The securing means may comprise one or more openings in the adaptorthrough which sutures may be attached. For example, the adaptor maycomprise one or more radially extending parts in which the one or moreopenings are provided. The securing means could alternatively compriseone of more hooks to which sutures may be attached.

The adaptor is preferably made of a plastics material such as a medicalquality polyamide. Alternatively, the adaptor may be made of medicalgrade POM, PEEK, or other similar polymer, a semi-rigid or flexiblemedical grade polymer such as Mediprene or similar, or titanium or othermetal or alloy, depending on the attachment mechanism and manufacturingmethod.

In some embodiments, a biologically degradable material is used to formthe adaptor. The adaptor would then “disappear” automatically after asuitable time, as it is dissolved by the surrounding tissue. Such anadaptor could be made of a medical grade polymer such as PGApoly(glycolide), PDO poly(p-dioxanone), LPLGpoly(L-lactide-co-glycolide), DLPLG poly(DL-lactide-co-glycolide) orPHB-PHV copolymer (polyhydroxybutyrate-polyhydroxyvalerate), forexample.

Different polymers or other materials will degrade at different rateswithin the body and therefore a polymer or other material should ideallybe used which has a suitable release/degradation rate. For example, amaterial which could form an adaptor that would degrade after a fewweeks (e.g. 2-8 or 5-7 weeks) may be suitable. Such an adaptor wouldremain in the body long enough for the healing process to take place.Also, factors such as mechanical properties, processing properties,possible sterilisation methods, cost and availability of the material,etc. should be considered when selecting a suitable material. Theadaptor is preferably arranged to receive the bowel segment therethroughand allow the bowel segment to be reverted back over the adaptor.

According to a further aspect of the invention, there is provided a kitcomprising an implant and an adaptor for securing a bowel segmentoutside a patient's body after an ostomy has been performed, the adaptorcomprising: attachment means for attaching the adaptor to the implant;and securing means to which a bowel segment may be attached.

The kit is preferably sterile.

The adaptor in the kit may be as described in relation to the adaptoraspect of the invention or any of its preferred features above.

The implant in the kit may be as described in relation to any of theimplant aspects of the invention or any of their preferred featuresabove.

The present invention also extends to a method of performing an ostomycomprising the use of an implant and/or adaptor as described above.

Thus, according to a further aspect there is provided a method ofperforming an ostomy comprising providing an ostomy implant according toany aspect or any preferred form thereof as described above; providing asuitable opening for the implant in the body of a patient; implantingthe implant in the opening and drawing a bowel segment into the implantto provide a stoma. The method is most preferably as described in moredetail below.

Viewed from a further aspect, the invention provides a method ofperforming an ostomy comprising: implanting a percutaneous ostomyimplant according to any aspect or any preferred form thereof asdescribed above in the abdomen; drawing a section of vessel (e.g. bowel)into the implant; and securing it to form a stoma. The implant and/ormethod are preferably as set out herein.

The implant is preferably used or provided in combination with a lid toprevent leakage and/or to protect the stoma. However, it may also beused in combination with a bag or an evacuation device. Thus, viewedfrom a still further aspect the invention provides an ostomy implantaccording to any aspect or preferred from described herein, incombination with a mating lid, bag or evacuation device. Mating istypically by means of a part of the lid, bag or evacuation device havinga part that in use engages with the exterior section of the implant andpreferably connects thereto by means of an engagement means, such as acircumferential groove around the circumference of the exterior sectionof the implant. However, it is possible for engagement to be wholly orpartially with an internal surface of the exterior section.

The invention also extends to a method of performing an ostomycomprising providing an ostomy implant, which is preferably (but notnecessarily) according to any aspect or any preferred form thereof asdescribed above; implanting the implant in an opening in the body of apatient; drawing a bowel segment into the implant to provide a stoma;providing an adaptor according to any aspect or any preferred formthereof as described above at an exterior end of the implant; revertingan efferent end of the bowel segment over the adaptor; and securing theefferent end of the bowel segment. The efferent end of the bowel segmentmay be secured with sutures, for example. The efferent end of the bowlsegment is preferably secured to the adaptor.

Preferably, the adaptor is removably attached to the exterior end of theimplant, for example with attachment means such as one or more clips.

After a few weeks, for example, when the intestine has grown enough intothe implant, the adaptor may be removed.

In order to remove the adaptor, preferably the part of the intestineprotruding outside the implant, which has now started to wizen, forexample, is cut away. The adaptor may then be removed. The intestineshould then reside permanently just at the top of the implant.

The invention also extends to a method of manufacturing an implant, theimplant being according to any of the aspects described above.Preferably, the implant is integrally formed. Alternatively, the implantmay be made in parts which are subsequently joined together. The partsmay be formed from the same material or two or more different materials.

The implant may be formed by a 3D printing process, for example.Preferably, an electron beam or a laser 3D printing process is used.Alternatively, the implant, or parts thereof, may be moulded orconventionally machined and laser or water-jet cut, or produced byetching and/or punching methods.

The method may comprise polishing at least part of the implant(particularly the exterior section, or the outer surface thereof). Thiscan give a smooth finish.

Any of the aspects of the invention described above may comprise any ofthe features of the other aspects of the invention, even if notspecifically stated.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will now be described by way ofexample only and with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of an embodiment of an implant;

FIG. 2 is another perspective view of the implant of FIG. 1;

FIG. 3 is a bottom view of the implant of FIG. 1;

FIGS. 4( a)-(c) are side views of the implant of FIG. 1;

FIG. 5 is a top view of the implant of FIG. 1;

FIG. 6 is a perspective view of another embodiment of an implant;

FIG. 7 is another perspective view of the implant of FIG. 6;

FIG. 8 is a bottom view of the implant of FIG. 6;

FIGS. 9( a)-(c) are side views of the implant of FIG. 6;

FIG. 10 is a top view of the implant of FIG. 6;

FIG. 11 is a perspective view of a porous structure;

FIG. 12 is a part cut-away perspective view of an implant with theporous structure of FIG. 11;

FIG. 13 is a perspective view of an implant with the porous structure ofFIG. 11;

FIG. 14 is a bottom view of the implant of FIG. 13;

FIG. 15 is a side view of the implant of FIG. 13;

FIG. 16 is a cross-sectional view of an implant along the line B-B inFIG. 15;

FIG. 17 is a cross-sectional view of an implant along the line A-A inFIG. 15;

FIG. 18 is a top view of the implant of FIG. 14;

FIG. 19 is shows the area labelled C in FIG. 17 in more detail;

FIG. 20 is the area labelled D in FIG. 16 in more detail;

FIG. 21 is another perspective view of the implant of FIG. 13;

FIG. 22 is a perspective view of part of a porous structure;

FIG. 23 is an exploded perspective view of the porous structure of FIG.22;

FIG. 24 shows a part of another porous structure;

FIGS. 25( a)-(c) show parts of the porous structure of FIG. 24 in moredetail;

FIGS. 26( a)-(f) show top, bottom, bottom perspective, top perspective,front and side views, respectively, of an embodiment of an adaptor;

FIG. 27 is a bottom perspective view of the adapter of FIGS. 26( a)-(f)attached to the implant of FIG. 6;

FIG. 28 is a top perspective view of the adapter of FIGS. 26( a)-(f)attached to the implant of FIG. 6; and

FIG. 29 is a perspective view of the adapter of FIGS. 26( a)-(f) and theimplant of FIG. 6 before attachment.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 to 5 show an embodiment of an implant 1.

The implant 1 is formed of an interior section 2 and an exterior section3. When implanted in a patient, the interior section 2 is located mostlyor entirely inside the patient whereas the exterior section 3 is locatedmostly or entirely outside of the patient.

The interior section 1 is formed of an inner interior section part 4 andan outer interior section part 8.

The inner interior section part 4 is a substantially cylindricalstructure formed of an hexagonal mesh. At its lower (as shown in thefigures) or inner end, the cylinder flares radially outwardly in aradially extending part 4 a and is terminated by a continuous solid ring5.

An anchoring flange 6 extends radially outwardly from the inner interiorsection part 4. This is also made of an hexagonal mesh. The anchoringflange 6 has at its radially outer edge a continuous solid ring 7. Theinner interior section part 4 extends both above and below (i.e.outwardly and inwardly from) the anchoring flange 6.

The anchoring flange 6 extends to a greater radius than the radiallyextending part 4 a.

The outer interior section part 8 connects the inner interior sectionpart 4 to the exterior section 3. The outer interior section part 8 isformed from a number of rods 9 extending between the inner interiorsection part 4 and the exterior section 3. The rods 9 are arrangedcircumferentially around the implant 1.

Some of the rods 9 are slanted with respect to the longitudinal axis ofthe implant 1 and others are parallel with it. The slanted rods areangled so that they can withstand rotational forces acting on theimplant 1. The rods which are parallel with the longitudinal axis of theimplant 1 are for withstanding loads acting on the implant 1longitudinally.

Some of the rods 9 have an exterior end which is located radiallyinwardly compared to the exterior ends of other rods 9. The interiorends of the rods 9 are all located at the same radius of the implant 1.

The rods 9 have a maximum diameter of 300 μm and a length of around 4.8mm. The slanting rods are slightly longer than the parallel rods.

The exterior section 3 is ring-shaped and has an outer circumferentialgroove 11 to which part of a lid or a connector (e.g. to a bag or otherdevice) or other device may be attached.

The exterior section 3 also has three indentations 12 into which anadaptor (such as the turnbull adaptor described below) or other devicemay be attached. The indentations 12 are arranged at equally spacedintervals around the outer circumference of the exterior section 3.

The interior surface of the exterior section 3 is formed from athree-dimensional porous structure 13 (not shown in detail here), suchas porous structure 213 or 313 described below.

All elements of the implant 1 are integral with each other and made fromthe same material. The implant 1 is formed entirely of titanium.

The implant 1 is manufactured using a laser 3D printing process. Afterthe implants 1 have been printed using the laser 3D printing process,the outer surface of the exterior section 3 is polished to give a smoothfinish.

Alternatively, the implant 1 may be moulded and/or made in parts whichare subsequently joined together.

FIGS. 6 to 10 show an embodiment of an implant 101 with a larger innerdiameter than the implant 1 of FIGS. 1 to 5.

However, like the implant 1 of FIGS. 1 to 5, the implant 101 is alsoformed of an interior section 102 and an exterior section 103. Theinterior section 102 is formed of an inner interior section part 104 andan outer interior section part 108.

The inner interior section part 104 has a radially extending part 104 awhich is terminated by a continuous solid ring 105.

An anchoring flange 106 extends radially outwardly from the innerinterior section part 104 and has at its radially outer edge acontinuous solid ring 107.

The outer interior section part 108 is formed of a number of rods 109extending between the inner interior section part 104 and the exteriorsection 103.

The exterior section 103 has an outer circumferential groove 111 andthree indentations 112. The interior surface of the exterior section 103is formed from a three-dimensional porous structure 113.

Other features of the implant 1 described above apply equally to theimplant 101.

FIG. 11 shows a porous structure 213. As shown in FIGS. 12 to 21, theporous structure 213 is in the form of a hollow cylinder or tube locatedat an inner surface of the exterior section 203.

The implant 201 shown in FIGS. 12 to 21 is generally similar to theimplants 1 and 101 described above so its structure will not bedescribed in detail. The only difference to implant 1 is that there areno indentations on the exterior section 203.

The implant 201 is formed of an interior section 202 and an exteriorsection 203. The interior section 201 is formed of an inner interiorsection part 204 and an outer interior section part 208.

The inner interior section part 204 has a radially extending part 204 awhich is terminated by a continuous solid ring 205.

An anchoring flange 206 extends radially outwardly from the innerinterior section part 204 and has at its radially outer edge acontinuous solid ring 207.

The outer interior section part 208 is formed of a number of rods 209extending between the inner interior section part 204 and the exteriorsection 203.

The exterior section 203 has an outer circumferential groove 211 but noindentations. The interior surface of the exterior section 203 is formedfrom the three-dimensional porous structure 213.

The porous structure 213 is completely permeable; there are no deadends. Every passage entering the porous structure also has an exit. Themaximum thickness of any member forming the porous structure is 300 μmand the maximum diameter of any opening is also 300 μm.

FIGS. 22 and 23 show a part of the porous structure 213 in more detail.It is formed from interconnecting members 215. The members 215 arearranged in layers 216 which are connected by connecting members 217.

In the embodiment shown, the members 215 and 217 form a regular,repeating pattern throughout the porous structure 213. However, in otherembodiments, the porous structure has an irregular structure. Theapertures in the porous structure have substantially square, rectangularor cross-shaped cross-sections. However, in alternative embodiments,some or all of the apertures are circular or oval.

FIGS. 24 and 25( a)-(c) show an example of another porous structure 313.This porous structure 313 is made up of a number of repeating sub-units314. Each of the sub-units 314 is formed of four members 315 joinedtogether at a central point of the sub-unit 314 at ends thereof. Sixsub-units 314 are joined together to form a generally hexagonal ring orunit 316. The units 316 are then joined together in a regular repeatingfashion to form the porous structure 313.

FIGS. 26( a)-(f) show an adaptor 500 for securing a bowel segmentoutside a patient's body after an ostomy has been performed.

The adaptor 500 is formed of a flattened ring 501 with a shortcylindrical part 502 protruding in a first direction from an innerdiameter of the ring 501. Three resilient members 503 protrude from thering 501 in an opposite direction to the cylindrical part 502.

The resilient members 503 are arranged equally spaced around the ring501 and each member 503 has a protruding part 505 located on a radiallyinward side of the resilient member 503 and towards an end of theresilient member 503 away from the ring 501.

The ring 501 has a number of slot-shaped apertures 504 (in this case,twelve) arranged around it circumferentially.

As shown in FIGS. 28 to 30, the adaptor 500 can be attached to theexterior section 103 of an implant 101. The protruding parts 505 of theresilient members 503 fit into the indentations 112, thereby attachingthe adaptor 500 to the implant 101 and preventing it from moving bothrotationally, transversally and longitudinally with respect to theimplant 101.

When attached, the adaptor 500 and the implant 101 have a common axisand the adaptor 500 is sized such that it can fit over and be attachedto the implant 101. The inner diameter of the adaptor 500 and theexterior section 103 of the implant 101 are the same.

The adaptor 500 is made entirely of plastic and is fabricated in a lasersintering process from medical quality polyamide powder (PA2200).

The adaptor 500 is sterilised by means of autoclaving and is providedsterile. Alternatively, the adaptor 500 may be sterilised by radiation,gas such as ethylene oxide, plasma or other methods.

The adaptor 500 is provided in different sizes, for example two sizes,to fit different sized implants (i.e. implants with differentdiameters).

The adaptor 500 is intended to be used during the surgical procedurewhen implanting an implant such as one described above. When attached tothe implant 101, the adaptor 500 can receive the bowel segmenttherethrough and allow the bowel segment to be reverted back over theadaptor 500.

The adaptor 500 can be used to fix the efferent intestine for around 4to 6 weeks after implantation, in order to provide best possiblestress-free healing and in-growth conditions for the ileum during theintegration process with the implant.

The adaptor 500 is attached to the exterior section 103 of the implant101 at the end of the implantation procedure. It is used to secure theefferent intestine with a few sutures, during the first four to sixweeks after implantation. Thereafter, the efferent intestine is cut awayand the adaptor 500 is removed.

In order to use the adaptor 500, the following steps are performed:

Clip the adaptor 500 onto the exterior section 103 of the implant 101.Turn it lightly to ensure it locks correctly in place.

The efferent end of the intestine is reverted over the adaptor 500 abovethe implant 101 and secured using sutures through the apertures 504.

Make sure that the groove 111 around the outside of the exterior section130 is free from tissue so that it can be used for attachment of astabiliser device (not shown). (A stabiliser device is a device used tosecure the implant 101 in place during the healing period by providingsupport against tilting or vertical movement of the implant 101. It canbe attached to the exterior section 103 of the implant 101, for example,and rests on the skin or a skin barrier.)

Anchor the intestine to the peritoneum using sutures.

After a few weeks the intestine should have grown enough into theimplant 101 for the adaptor 500 to be removed. The part of the intestineprotruding outside the implant 101 will now have started to wizen and iscut away. The adaptor 500 is removed and the intestine will residepermanently just at the top of the implant 101.

In order to remove the adaptor 500, the following steps are performed:

Remove any stoma bag and clean the orifice gently.

Carefully remove the stabiliser device and the stoma skin barrier.

Gently rinse around the implant 101 to remove any intestinal content orliquid.

With a diathermy scalpel, incise the intestine inside of adaptor 500three millimetres from the top through the entire thickness of theintestine.

If needed, dissect the intestine down to the base of the adaptor 500with a forceps. Do not to go beyond the base of the adaptor 500 as thiscould cause harm to the tissue in-growth into the implant cylinder,resulting in leakage.— With a pointed object, carefully lift theresilient members 503 out of the indentations 112 in the exteriorsection 103 and remove the adaptor 500 slowly.

With dissection scissors, trim any excess tissue that remains above theexterior section 103 of the implant 101. If catheterization is needed,do not to touch the inside (interior diameter) of the implant 101.

Put a new skin barrier, stabiliser and stoma bag in place.

What is claimed is:
 1. An implant comprising a tubular interior sectionfor implantation into a patient and an exterior section connected to theinterior section, wherein the interior section comprises a plurality ofrods and the rods have a diameter of less than or equal to 500 μm.
 2. Animplant as claimed in claim 1, wherein the rods are arrangedcircumferentially around the implant.
 3. An implant as claimed in claim1, wherein one or more of the rods is slanted with respect to thelongitudinal axis of the implant.
 4. An implant as claimed in claim 1,wherein one or more of the rods is parallel with respect to thelongitudinal axis of the implant.
 5. An implant as claimed in claim 1,wherein one or more rods has at least one end located radially inwardlywith respect to the implant compared to other rods.
 6. An implant asclaimed in claim 1, wherein the rods have a diameter of less than orequal to 450 μm, less than or equal to 400 μm, less than or equal to 350μm, less than or equal to 300 μm, or less than or equal to 250 μm.
 7. Animplant as claimed in claim 1, wherein the interior section comprises aninner interior section part and an outer interior section part, whereinthe outer interior section part comprises the plurality of rods.
 8. Animplant as claimed in claim 7, wherein the plurality of rods connect theinner interior section part to the exterior section.
 9. An implant asclaimed in claim 8, wherein the inner interior section part is connectedto the exterior section solely by the plurality of rods.
 10. An implantas claimed in claim 7, wherein the outer interior section part is formedsolely from the plurality of rods.
 11. An implant as claimed in claim 7,wherein the inner interior section part comprises an ingrowth means,preferably in the form of a mesh.
 12. An implant as claimed in claim 1,wherein at an inner end, the interior section extends radiallyoutwardly.
 13. An implant as claimed in claim 1, further comprising ananchoring flange extending radially outwardly from the interior section.14. An implant as claimed in claim 13, wherein the anchoring flange isformed from a mesh.
 15. A implant as claimed in claim 1, in combinationwith a mating lid, bag and/or evacuation device.
 16. An implantcomprising: an exterior section having a body for attachment to anadaptor or other removable device, first and second ends, and inner andouter surfaces extending between the first and second ends, with thesecond end having a width extending radially between the inner and outersurfaces of the exterior section; a tubular mesh having first and secondends; and a plurality of rods joining the second end of the exteriorsection to the first end of the tubular mesh, wherein the rods areattached at different points on the width and along the circumstance ofthe second end of the exterior section, and extend to and attach atdifferent points on the circumference of the first end of the tubularmesh, with the rods providing lesser material than the tubular mesh toreduce adverse reactions thereto by a patient who receives the implant.